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Alector Announces Appointment of Shehnaaz Suliman, M.D., MBA, M.Phil., as President and Chief Operating Officer

On December 11, 2019 Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology company pioneering immuno-neurology, reported the appointment of Shehnaaz Suliman, M.D., MBA, M.Phil., as the company’s president and chief operating officer (Press release, Alector, DEC 11, 2019, View Source [SID1234552251]). In this new role, Dr. Suliman will oversee Alector’s day-to-day operations, including preclinical development, program management, and strategic and administrative functions. Dr. Suliman will report to Arnon Rosenthal, Ph.D., chief executive officer of Alector.

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"Shehnaaz’s background and expertise in drug development, strategy, portfolio management, and operational leadership uniquely position her to bring greater integration to our operations. Her strong track record of building and leading teams that can support the development of life-changing medicines comes at a key inflection point for Alector as we prepare to launch our first registrational trial in 2020," said Dr. Rosenthal. "Shehnaaz’s core leadership strengths will be invaluable to our entire organization, and we look forward to leveraging her insights as a thought partner and leader at Alector."

"Neurodegeneration affects millions of patients and families worldwide, and I am proud to be supporting Alector’s mission to find a cure for these diseases. As the leader in immuno-neurology, Alector has made substantial progress in rapidly advancing a broad clinical portfolio of novel and innovative programs," said Dr. Suliman. "As we advance our lead programs into late-stage clinical development and continue to progress our research pipeline, I look forward to partnering with the team to further our vision for finding cures for neurodegenerative diseases. I am excited to be joining the company at this important time and look forward to helping Alector execute our objectives and scale our organization effectively."

Dr. Suliman brings over 20 years of business development, drug development, strategic and operational expertise, and executive leadership skills to Alector. She joins Alector from Theravance Biopharma, where she served as senior vice president, corporate development and strategy, a position she held from July 2017 to March 2019. Prior to Theravance, Dr. Suliman worked for Genentech as a group leader and project team leader in the R&D Portfolio Management and Operations Group from September 2010 to May 2015 where she led and oversaw a number of neuroscience development programs. She was also vice president and global therapeutic head, Roche Partnering from June 2015 to July 2017. Dr. Suliman held various management roles of increasing responsibility at Gilead Sciences between January 2005 and September 2010. Before Gilead, Dr. Suliman was an investment banker with Lehman Brothers and Petkevich & Partners, advising public and private companies on buy- and sell-side transactions. She is a member of the board of directors of Ultragenyx Pharmaceutical, a biopharmaceutical company, and 10X Genomics, a life science technology company. Dr. Suliman received her M.D. from the University of Cape Town Medical School, South Africa, and holds an MBA, with distinction, and M.Phil. in development studies from Oxford University, where she was a Rhodes Scholar.

Lilly Opens First Ever Randomized Phase 3 Clinical Trial in Treatment-Naïve RET Fusion-Positive Non-Small Cell Lung Cancer

On December 11, 2019 Eli Lilly and Company (NYSE: LLY) reported the opening of the LIBRETTO-431 clinical trial [NCT04194944] for selpercatinib, also known as LOXO-292, for treatment-naïve RET fusion-positive non-small cell lung cancer (NSCLC) patients (Press release, Eli Lilly, DEC 11, 2019, View Source [SID1234552245]). Enrolled trial participants will be randomized to receive either selpercatinib or platinum-based (carboplatin or cisplatin) and pemetrexed therapy with or without pembrolizumab as initial treatment of their advanced or metastatic RET fusion-positive NSCLC.

"Given the remarkable results of the LIBRETTO-001 trial, I am excited to open this important Phase 3 trial of selpercatinib, a highly selective and potent molecule that has previously demonstrated sustained responses with a well-tolerated safety profile," said Professor Ben Solomon, principal investigator at the Peter MacCallum Cancer Centre in Melbourne Australia. "This trial endeavors to generate outcome data that place patients with RET fusions alongside those with EGFR mutations and ALK fusions, as driver-positive populations that should be treated with targeted therapies in the first-line setting, rather than chemoimmunotherapy."

"This is an important milestone in the journey to further demonstrate the benefit of selpercatinib and the potential for people living with advanced or metastatic RET fusion-positive non-small cell lung cancer in the first-line setting against the current standard of care," said Anne White, president of Lilly Oncology. "Launching a trial of this size underscores the importance of now including RET fusions in the paradigm of genomic testing in lung cancer."

Trial Background
LIBRETTO-431 is a randomized Phase 3 clinical trial of patients with treatment-naïve RET fusion-positive NSCLC. The trial will enroll 400 patients with advanced or metastatic RET fusion-positive NSCLC who have received no prior systemic therapy for metastatic disease. Enrolled trial participants will be randomized 1:1 to receive either selpercatinib or platinum-based (carboplatin or cisplatin) and pemetrexed therapy with or without pembrolizumab as initial treatment of their advanced or metastatic RET fusion-positive NSCLC. RET fusions may be identified using local testing. This trial’s primary endpoint is progression-free survival (PFS) and secondary endpoints include overall survival (OS), overall response rate (ORR), duration of response (DoR), and intracranial ORR. For patients randomized to the control arm, crossover is allowed at progression.

About Selpercatinib (LOXO-292)
Selpercatinib, also known as LOXO-292, is a highly selective and potent, oral investigational new medicine in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase. RET fusions and mutations occur across multiple tumor types with varying frequency. Selpercatinib was designed to inhibit native RET signaling as well as anticipated acquired resistance mechanisms.

Selpercatinib has received breakthrough designations in RET fusion-positive NSCLC, RET-mutant medullary thyroid cancer (MTC) and RET fusion-positive thyroid cancers.

About RET-Altered Cancers
Genomic alterations in RET kinase, which include fusions and activating point mutations, lead to overactive RET signaling and uncontrolled cell growth. RET fusions have been identified in approximately 2 percent of non-small cell lung cancer, 10-20 percent of papillary and other thyroid cancers and a subset of other cancers. Activating RET point mutations account for approximately 60 percent of MTC. RET fusion cancers and RET-mutant MTC are primarily dependent on this single activated kinase for their proliferation and survival. This dependency, often referred to as "oncogene addiction," renders such tumors highly susceptible to small molecule inhibitors targeting RET.

Tetra Bio-Pharma Provides Update on its Hepatocellular Carcinoma Drug HCC011

On December 10, 2019 Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (TSX-V:TBP) (OTCQB:TBPMF), a leader in cannabinoid-derived drug discovery and development, reported it will be requesting a meeting with the U.S. Food and Drug Administration (FDA) to discuss the drug development program for its Orphan Drug candidate HCC011, inhaled delta-9-tetrahydrocannabinol (THC), in the treatment of hepatocellular carcinoma (Press release, Tetra Bio Pharma, DEC 10, 2019, View Source [SID1234561119]).

Hepatocellular carcinoma (HCC), also known as primary liver cancer, is the most common form of liver cancer and is responsible for 80 percent of the primary malignant liver tumors in adults. In addition to quality of life benefits to cancer patients, based on preclinical research, HCC011 should also have antitumor effects. The Phase 2 study of HCC011 will target patients with disease progression on Sorafenib, have measurable disease, and Child-Pugh Class A liver impairment. The Phase 2 trial will consist of a single arm. Patients will receive the HCC011 by inhalation three times daily, in combination with Sorafenib, until disease progression or unacceptable toxicity. The study design is similar to the ones used by recent drugs seeking accelerated approval. The Disease control rate will be assessed based on the Response Evaluation Criteria in Solid Tumors (RECIST); the overall survival and time to progression will be closely monitored over time. Patients will also beneficiate of the anti-emetic effect of HCC011, which will participate in improving their quality of life.

The company intends to file an NDA for HCC011 via the 505(b)(2) pathway. The FDA has three approval pathways by which drugs may gain approval and the 505(b)(2) new drug application (NDA) is one of the three ways created by the Hatch-Waxman Amendments of 1984, with 505(b)(2) referring to a specific section of the U.S. Federal Food, Drug, and Cosmetic Act. The provisions of a 505(b)(2) provide manufacturers who have certain types of drugs with an opportunity to acquire FDA approval without performing all the work that’s required with a standard 505(b)(1) NDA.

Additionally, 505(b)(2) pathway allows for the ability to pursue additional designations such as fast track and accelerated approval to complement its already granted Orphan Drug Designation for HCC011 in HCC. Orphan drug designation provides certain benefits and incentives, such as seven-year marketing exclusivity, protocol assistance from the FDA, tax credits of 50% of the clinical drug testing cost awarded upon approval, and a waiver of the prescription drug user fee. The company fully intends to seek out additional designations where appropriate.

The HCC011 orphan drug candidate benefits from Tetra’s significant clinical data on the pharmacokinetics, safety and pharmacodynamics of inhaled cannabinoids. The company will also benefit from its previous investment in its GMP compliant manufacturing facility for these inhaled new drugs that holds an active Drug Establishment License (DEL) from Health Canada.

"We are very excited to bring HCC011 to clinical trials to help patients suffering from hepatocellular carcinoma and believe the 505(b)(2) pathway is the right approach for us, as we will be able to leverage our data and the data of others," said Dr. Guy Chamberland, CEO and Chief Regulatory Officer of Tetra Bio-Pharma. "This regulatory strategy combined with the Orphan status will provide major cost savings to shareholders. Post our meeting with FDA, we hope to gain clarity on our filing and marketing requirements, including input from the Agency on the design of our planned Phase 2 trial for HCC011 in HCC. We plan to provide an update once we have concurrence with the FDA."

Bloom Science Collaborates with Cedars-Sinai Medical Center to Expand Microbiome Research and Discovery into Brain Cancer

On December 10, 2019 Bloom Science, a biopharmaceutical company developing microbiome-derived therapeutics in multiple neurological conditions and oncology, reported the launch of a research agreement with Cedars-Sinai Medical Center (Press release, Bloom Science, DEC 10, 2019, View Source [SID1234556212]). The collaboration will focus on advancing the understanding of the microbiome in a Phase 1 study investigating the clinical utility of the ketogenic diet as an adjunctive treatment in combination with standard of care in glioblastoma.

Preclinical and early clinical research has focused on elucidating the impact of the ketogenic diet in the treatment of glioblastoma multiforme, one of the deadliest primary brain tumors. Bloom Science will leverage its discovery platform to investigate the underlying contributions of the microbiota and related metabolites.

"For a disease like glioblastoma, where decades of clinical trials have resulted in only marginal improvement, we need to think differently about how to approach treatment. Although we still have a great deal to learn, it is clear that diet, metabolism, and the gut microbiome have a profound effect on health, disease, and treatment response," said principal investigator Jethro Hu MD, at Cedars-Sinai Medical Center Samuel Oschin Comprehensive Cancer Institute. "To reach the next level of scientific understanding, we need to bring leading edge research capabilities to the table, and that is precisely what this collaboration provides."

"The gut microbiome is a very promising frontier in both neurological and oncology drug development," said Christopher Reyes, PhD, CEO of Bloom Science. "This research agreement is key to expanding our discovery efforts into oncology, cancer related cognitive decline, and our commitment to working with leaders in the field, such as Dr. Hu to further advance the science."

AffaMed Therapeutics Receives NMPA Approval to Initiate Phase III Clinical Trial in China with Herceptin® (Trastuzumab) Biosimilar Candidate AMT901

On December 10, 2019 AffaMed Therapeutics, a biopharmaceutical company founded and funded by CBC Group, a healthcare private equity firm focused on the development and late-stage investment opportunities, reported it has received Clinical Trial Application (CTA) approval from the China National Medical Products Administration (NMPA) to conduct clinical trials for AMT901, or SB3, a proposed biosimilar for Herceptin (trastuzumab) being developed in collaboration with Samsung Bioepis as an intravenous trastuzumab for the treatment of HER2-positive breast cancer and it has been approved by the European Medicines Agency (EMA) and United States (US) Federal Drug Agency (FDA) (Press release, AffaMed Therapeutics, DEC 10, 2019, View Source [SID1234553305]). Clinical study preparation is on track and first patient visit is scheduled in Q1 2020.

"This CTA approval is an important milestone for AffaMed as we transition to a clinical-stage biotechnological company," said Dr. Nathan Pang, CEO of AffaMed. "We are fully geared up to initiate this clinical development program, with the goal of providing AMT901 to help more Chinese patients at an affordable price."

The CTA approval was based on review of a comprehensive data package that demonstrated biosimilarity of AMT901 to Herceptin (trastuzumab). This includes results from a clinical comparative study that found no clinically meaningful differences in terms of efficacy and safety between AMT901 and the reference product for patients with HER2-positive breast cancer.

In February 2019, CBC Group formed AffaMed Therapeutics and announced a partnership agreement with Samsung Bioepis to collaborate on clinical development, regulatory registration, and commercialization of multiple next-generation biosimilars in China. In addition to the AMT901, AffaMed has a growing portfolio of product pipelines including in the ophthalmology therapeutic area, with biosimilars referencing Lucentis (ranibizumab) and Eylea (aflibercept) also in clinical development in collaboration with Samsung Bioepis.